Senior Clinical Pharmacokineticist I

Employer
AbbVie
Location
Lake County, IL, US
Posted
Jul 27, 2018
Ref
1803049
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Clinical Pharmacology and Pharmacometrics Organization leads the strategy, generation/analyses/interpretations/reporting of data and communications/agreements with global regulatory agencies in the areas of Clinical Pharmacology, Pharmacokinetics, Exposure-Response and Biopharmaceutics. The organization supports all phases of pharmaceutical research and development from Discovery to Development to On Market Support for all new molecular entities and marketed products in all therapeutic areas (antiviral, immunoscience, neuroscience, pain, metabolic disease, men and women's health, renal disease and oncology). The organization is responsible for defining the relationship between drug exposure (e.g., concentrations in blood) and efficacy measures (primary and/or secondary clinical outcomes or biomarkers) to select the optimal dose and dosing intervals. CPPM is also responsible for defining the relationship between drug exposure and safety measures (clinical outcomes or biomarkers (e.g., QTc)) to identify populations that may be at risk of increased toxicity or decreased tolerability. CPPM performs the selection, design and interpretation of all Phase I studies including first in human, bioavailability/ bioequivalence/food effect, drug interaction, pilot/ definitive cardiovascular (QTc), special population, pharmacogenetic and immunogenicity studies. The organization provides critical support for conducting technical due diligence of new business opportunities (both in-licensing and out-licensing) by assessing probability of success for achieving Target Product Profile (TPP). CPPM contributes to responses to defend our intellectual properties and extension of patent protection, provides critical support for life-cycle management of marketed products, responds to questions from post-marketing safety, legal, pharmaceutical manufacturing and regulatory for marketed products world-wide, and publication of scientific information in patents and manuscripts.

Primary Job Function:

  • Executes clinical PK/PD research or development that achieves project and therapeutic area goals
  • Understands PK/PD and related regulatory advances, strengths, weaknesses, opportunities and threats, and assists with responses and appropriate new strategies
  • Demonstrates PK/PD excellence, work ethic, and dedication to team/project goals
  • Effectively presents data and technical information
  • Investigates, identifies, develops, and optimizes new PK/PD models
  • Acts as a lead Pharmacokineticist on one or more studies
  • Critically evaluates relevant PK/PD and regulatory advances, and integrates this knowledge into development programs when applicable
  • May contribute to due diligence

Core Job Responsibilities:
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures
  • Utilizes PK/PD expertise to provide PK/PD consultation to the business and leadership on decisions and development plans for multiple projects within a therapeutic area
  • Develops productive collaborations and communications with functional and technical experts across multiple disciplines to facilitate PK/PD achievement
  • Writes and communicates PK/PD materials
  • Communicates/presents key PK/PD information to senior management
  • Serves as liaison to other departments for multiple studies
  • Assists in the development of commercial and regulatory strategies by formulating PK/PD plans including development activities
  • Contributes to the development of PK/PD plans to satisfy regulatory expectations and defends plans and interpretation of data to GPRD management
  • Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact)
  • May contribute to due diligence
  • Contributes to PK/PD interpretations of reports for regulatory filings and clinical protocols
  • Primary contributor to interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions
  • Author in peer-reviewed journals, R&D reports, and/or regulatory documents/filings
  • Uses external information to gain competitive intelligence
  • Act as advocate for integrating this knowledge into the project team's research efforts


Position Accountability / Scope:

  • Receives assignments from Director/ Associate Director/Assistant Director and is responsible for completing tasks on schedule with minimal supervision
  • Reviews key decisions impacting PK/PD timelines with department management
  • May attend project team meetings and reviews key scientific decisions impacting project timelines with department management
  • Demonstrates a high degree of responsibility in maintaining PK/PD standards, GxP compliance, and safe operating practices for self
  • Participates in establishing project goals, defining short and long-term PK/PD strategies, and contributes to the generation of project-related documents and presentations
  • Keeps accurate and current records of project related activities according to AbbVie policies


For Senior Clinical Pharmacokineticist I:
  • PhD in field related to Pharmacokinetics
  • Proficient in PK/PD or related analyses
  • Identifies technical issues impacting project and elevates to management for resolution
  • Participates in process improvement initiatives

Equal Opportunity Employer Minorities/Women/Veterans/Disabled